| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01301-1 |
| Product Name/Description |
Eclipse Treatment Planning System, ARIA Radiation Oncology (treatment plan and image management application) and Acuity Radiation Therapy Simulator
Software versions 11 and 13
Product codes: H48, HIT and H77
ARTG Numbers: 119983, 132638, 119995 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
10/12/2013 |
| Responsible Entity |
|
| Reason/Issue |
A software anomaly has been identified with the Plan Parameters workspace within Eclipse Treatment Planning System, ARIA, and Acuity. When a dose relevant parameter is changed and "Do not clear MUs and Reference Point dose" is selected, the Monitor Units (MUs) may change without the User being aware of the changes. When the user follows a specific set of conditions, the dose is rescaled such that the 100% isodose is shifted to the primary reference point location. Consequently, the MUs for each treatment field will change and will not meet the dose prescription intended. For example, if the dose prescription percentage was 85% in the original plan, and a dose relevant parameter is changed, the dose prescription percentage will rescale to 100%. The Monitor Units will be correspondingly increased. Thus, the plan will no longer meet the intended dose prescription. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised not to use the Plan Parameters workspace to modify 3D Treatment Plans containing a 3D dose. When it is necessary to edit patient treatment plans containing 3D dose, this action must be performed in Eclipse External Beam Planning or in the applicable treatment planning system. Varian Medical Systems recommends a thorough review of treated patient plans for plans with a primary reference point with geometric location and where modifications were made in the Plan Parameter workspace. Varian Medical Systems is currently developing a technical correction for this issue. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 657 036 - Varian Oncology Help Desk |